Manager QA, External Audit

Job Overview: Manages and ensures proper execution of the audit and inspection programs. Summary of Responsibilities: Oversees and leads execution of client audit, for-cause audit and regulatory inspection end to end activities Ensure the consistent implementation, use and review of SOPs. Escalate issues to management in a timely manner implementing appropriate solutions, including preventative actions. Negotiate with functional and operational internal stakeholders to improve quality and increase efficiencies. Analyze and interpret data to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance and Quality Assurance (RC and QA) processes. Lead and effectively manage constructive crucial interactions with clients or regulatory agencies. Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance and Quality Assurance (RC and QA) processes. Interpret applicable quality regulations/standards and create appropriate policies and procedures. Ensure Regulatory Compliance and Quality Assurance (RC and QA) management responsibilities, as indicated in applicable controlled documents, are followed. Conduct internal audits as directed, such as process/system and service provider quality assessment for qualification/requalification All other duties as needed or assigned. Qualifications (Minimum Required): A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience). Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience may be substituted for education. Experience (Minimum Required): 10+ years of experience in regulatory environment (experience in GXP roles). Experience and regulatory expertise of industry quality systems/standards. Ability to interpret applicable regulations/standards. Experience in leading process improvement initiatives. Ability to communicate and negotiate with internal stakeholders effectively. Physical Demands/Work Environment: Some overtime and weekend work may be required. Travel Required. Learn more about our EEO & Accommodations request here.